Exclusions to Patent rights............................................................................................... 80 United States ............................................................................................................................. 80

Exceptions and limitations to patentee's rights ................................................................. 84 United States ............................................................................................................................. 84

Exemption for medical practitioners and their institutions ...................................................... 84

Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights - Biotechnology

I – Preliminary considerations

Purpose and areas of study

In the second tranche of our mandate, we are supposed to cover such ―exclusions,

exceptions and limitations where incentives through exclusive rights are unnecessary or incentives are provided by alternative protection mechanisms‖ related to biotechnology patents issuing, including plants, animals and other life forms.

The conditions related to strictly pharmaceutical or veterinary inventions, will not be covered by this study, except to the extent they have also specific biotechnological

import. Information was gathered, however, with regards to human and animal

including the living material deposit in specialized institutions to provide access to genetic information. As they are not exclusions, exceptions or limitations, they are not covered hereby.

Exclusions, exceptions and limitations

Our purpose is to identify those exclusions, exceptions and limitations directed specifically to such area of technology; therefore, we shall not deal on other aspects of patent law related to that field.

1 The main discussion of this issue is covered in the sister article "Patent exclusions that promote public health objectives", by Shamnad Basheer, ShashwatPurohit and Prashant Reddy. A considerable number of domestic laws, however, cover methods of treatment of animals (other than humans), which shall not

Act, 1970 excluded from patentability ―any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render

them free of disease or to increase their economic value or that of their products”. Here also, the

biotechnological value surpassed the purely health issue. As shall be seen below, this extension of the exclusion to plants was eventually excised from Indian law.

2 As to disclosure of genetic sources of the object of patents, see below. As further mentioned, this matter, being the subject of International discussions in course on very specific basis (the 1992 Biodiversity Convention) and included in a relatively small number of national laws, will not be extensively discussed in this study.

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For the purposes of this study, we use the term "exclusion" to refer to subject matter exclusions and "exceptions" as encompassing not only exclusions of patentee's rights

3but also limitations on those rights.

3 As to the interpretation of what are "exceptions, exclusions and limitations" in the field of biotechnology and its conditioning factors under TRIPs, see the recent EU Case of Monsanto Technology LLC v Cefetra

BV, Case C-428/08,6 July 2010, "76. On the assumption that ‗exceptions to rights conferred‘ could be regarded as encompassing not only exclusions of rights but also limitations on those rights, it should be pointed out that an interpretation of Article 9 of the Directive limiting the protection it confers to situations in which the patented product performs its function does not appear to conflict unreasonably with a normal exploitation of the patent and does not ‗unreasonably prejudice the legitimate interests of

the patent owner, taking account of the legitimate interests of third parties‘, within the meaning of Article 30 of the TRIPS Agreement".

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II - Biotechnology protection: a precarious convergence?

A peculiar aspect of the current patent regime is the relative convergence of the standards of exclusions from patentable subject matter and exceptions and limitations to

4the rights in connection with biotech matter . The basis here for evaluation of

tendencies and variations is the model of TRIPs Art. 27.

Two trends could be discerned: a quite liberal pattern epitomized by the American patent system, and a more contained system as indicated by the European directive and

5to some extent EPO practice. The details of those two trends are voiced below . All

other national or regional systems could be to a certain extent affiliated to one of those trends.

What should be taken as a rather crucial consideration is that the patent system is only one aspect of the IP approach to the biotechnology protection; not only the neighboring plant varieties apparatus is a necessary adjunct to this analysis (though outside the scope of the present study) as many other extra-IP aspects impact directly on the effectiveness

6of this protection. The Convention of Biological Diversity (1992) and the FAO Treaty

4 UNCTAD-ICTSD. Resource Book on TRIPS and Development. New York: Cambridge University Press, 2005, p. 388: "Since the adoption of the Agreement, the differences in the treatment of biotechnological inventions among developed countries have been reduced, but not eliminated", noting "plant varieties and animal races are not patentable in Europe, while they are eligible for protection in the USA".

5 Some inklings of a prospect of increasing divergent models could be discerned: organizations of the civil society in Europe and some developing countries are taking a more active role in constraining the further advancing of patent and plant varieties rights on biotechnological creations. See International

Experts See Backswing In Pendulum Of Biological Patenting/By Monika Ermert for Intellectual Property Watch. 21 July 2010, found at http://www.ip-watch.org/weblog/2010/07/21/international-experts-see-

backswing-in-pendulum-of-biological-patenting/. Even though some authors indicate a somewhat

analogous trend in US current case law (based on macroeconomic efficiency), it would seem that the momentum in the two systems is not the same.

6 As to the issue, seeCommunication from India. IP/C/W/195, 12 July 2000; ―The Relationship between the TRIPS Agreement and the Convention on Biological Diversity and the protection of Traditional knowledge‖, submission by Brazil on behalf of the delegations of Brazil, China, Cuba, Dominican Republic, Ecuador, India, Pakistan, Thailand, Venezuela, Zambia and Zimbabwe, IP/C/W/356, 24 June 2002; ―Taking Forward the Review of Article 27.3(b) of the TRIPS Agreement‖, Joint Communication from the African Group, IP/X/W/404, June 26, 2003; ―Review of article 27.3(b) of the TRIPS Agreement, and the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the protection of traditional knowledge and folklore. A concept paper", Communication from the European Communities and their Member States, IP/C/W/383, 17 October 2002; ―The Relationship

between the TRIPS Agreement and the Convention on Biological Diversity and the Protection of Traditional Knowledge‖, submission by Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, India, Peru,

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7(2001), to mention only two International instruments of broad import, incorporate provisions that condition the scope of protection (or subject its economic results) to

8some constraints . Furthermore, this area is probably where more urgently new legal regimes to cover the periods (for instance, the research phases) should be sought in

9which it is not yet possible to obtain a patent or a Plant Variety Right.

10Developing country systems have raised some marginal variations in these standards .

The issue of protection of selection or purification of objects found in nature has some

11importance in South America and other area, as in Pakistani and Thai Laws . The

disclosure requirements regarding origin and legal provenance of biological material would seem to be a very significant theme within the evolving International patent law,

Thailand, Venezuela, IP/C/W/403, June 24, 2003; ―Elements of the obligation to disclose the source and

country of origin of biological resources and/or traditional knowledge used in an invention‖, submission from Brazil, India, Pakistan, Peru, Thailand, and Venezuela, IP/C/W/429 of September 21, 2004. 7 In addition, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), see http://www.planttreaty.org/. In its relevant provision, such treaty states: "Article 12.3 (d) Recipients shall not claim any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components, in the form received from the Multilateral System‖. On the issue of potential ITPGRFA/patent clashes, see Kathryn Garforth and

Christine Frison, Key Issues for the relationship between the Convention on Biological Diversity & the International Treaty on Plant Genetic Resources for Food and Agriculture, July 2007, found at http://www.qiap.ca/pages/documents/OP2-Final_000.pdf, visited on 08/20/10.

8 For the impact of those treaties to the issue under analysis, see Bertacchini, Enrico, Biotechnologies, Seeds and Semicommons. Available at SSRN: http://ssrn.com/abstract=960747visited on 08/20/10. 9 Those issues are, among many other: (a) the blurring of the science/technology distinction (and the discovery/technical solution question); (b) the appropriation paradigm in connection with multi-party, public/private research environment; (c) the interference with environmental, biodiversity, health and food International and domestic legal systems (d) the raising of ethical issues. Some researchers and graduate candidates under the supervision of this author exploring specifically the question of pre-patent protection of developing biotech-related technologies, especially in connection with the prevailing model of joint research in this area, where public and private funding and initiative are particularly intertwined. See as to the multi-party issue Maria Ester Dal Poz and Denis Borges Barbosa, Incertezas e riscos no patenteamento de Biotecnologias: a situaçãobrasileiracorrente, in Vanessa Iacomini, Propriedade

Intelectual e Biotecnologia, JuruáEditora, 2007, found at

http://denisbarbosa.addr.com/arquivos/200/propriedade/esterdenis.pdf. As to the pre-patent appropriation issue, see Lessa, Marcus, Contracting Innovation (June 18, 2009). Available at SSRN: http://ssrn.com/abstract=1431469 and JENNEJOHN, Matthew C. Collaboration, Innovation, and Contract Design.Columbia Law and Economics Working Paper Series, no. 319, June 2007. SSRN:

10 Not necessarily towards a curtailment of protection. See Borges Barbosa, Denis and Lessa, Marcus, The

New Brazilian Government Draft Law on Plant Varieties (Or… How a Developing Country May Want to Enhance IP Protection Because It May Actually Need It) (June 6, 2009). Available at SSRN: http://ssrn.com/abstract=1415406 .

11 The relevant provision excludes both naturally found items "or extracts from animals or plants".

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but would hardly be classifiable as an exception or limitation to the patent right under

12the scope of this study.

12 See Doc. WIPO/GRTKF/IC/16/6 Prov. The specific Brazilian current situation is described in Doc. WIPO/GRTKF/IC/16/INF/9.